Clinical Outcomes for Anatomic Nerve Sparing Radical Perineal Prostatectomy
The purpose of our study is to evaluate perioperative, oncologic, and functional outcomes
for the anatomic radical perineal prostatectomy. The anatomic radical perineal
prostatectomy is standard-of-care surgical approach to the surgical management of localized
prostate cancer. The operative technique selected for radical prostatectomy is largely
based on patient preference after appropriate counseling, and surgeon recommendation based
on surgical considerations and surgeon experience. Outcome data for the anatomic radical
perineal prostatectomy will represent a valuable addition to the published body of
literature. Our study is a prospective clinical outcome data collection and analysis and we
will be looking at data within several domains. First, perioperative data will be collected
to evaluate the OR time, blood loss, surgical complications, and length of hospital stay for
the anatomic radical perineal prostatectomy. Second, oncologic efficacy of this procedure
will be reported, based on margin status of surgical specimens, which will be correlated
with tumor features (Gleason score, tumor volume, pre-op PSA score). Third, functional
outcomes will be evaluated by comparing urinary, sexual, and bowel function in the pre-op
and post-op settings. This third domain will be accomplished by employing the following
validated questionnaires (attached - SHIM, IPSS, and EPIC-26). These questionnaires will be
filled out at 3 time-points: pre-op, and at 3 months and 12 months post-operatively.
Observational
Observational Model: Cohort, Time Perspective: Prospective
Surgical margin-free rate
June 2011
No
Jason B. Wynberg, MD, FACS
Principal Investigator
Maimonides Medical Center
United States: Institutional Review Board
09-05-VA02
NCT00922818
June 2009
June 2012
Name | Location |
---|---|
Maimonides Medical Center | Brooklyn, New York 11219 |